NDA vs. OTC Monograph: Which Pathway is Right for You?

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One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market.
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OTC Monograph User Fees are Cancelled for FY2020

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Surprising news emerged from the FDA early this week – OTC Monograph User Fee program (OMUFA) facility fees for fiscal year 2020 have been dropped.
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FDA Announces New Changes to Permitted Marketing Status of OTC Monograph Drugs

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In a recent webinar hosted by the FDA, Dr. Theresa M. Michele, director of the Office of Nonprescription Drugs at CDER, revealed a significant update on the generally recognized as safe and effective (GRASE) status of hundreds of Monograph ingredients.
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OTC Monograph Drug Reform Changes the Pharmaceutical Landscape

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On March 27, 2020, Congress and the House of Representatives with the support of the President signed into law a $2 trillion stimulus bill to address the dramatic economic impact caused by the coronavirus pandemic. Better known as the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the bill includes a provision for over-the-counter
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